NCT07168798

SpO2 Accuracy in Children

Evaluation of SpO2 Accuracy in Children With Various Skin Color

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 180 (estimated)
• Sponsor: Nihon Kohden · Industry
• Sex: All
• Age: 0 Days – 12 Years
• Healthy volunteers: Accepted

Summary

Evaluation of SpO2 Accuracy in Children with Various Skin Color

Detailed description

Pulse oximeters, which estimate blood oxygen levels, are routinely utilized for monitoring. However, research has shown that these devices may provide higher readings for individuals with darker skin tones as compared to individuals with lighter skin tones. This inaccuracy can result in unnoticed or untreated low oxygen levels, particularly affecting racial and ethnic minorities. It is beneficial for patients and healthcare providers to evaluate the accuracy of pulse oximeter oxygen saturation (SpO2) readings from pulse oximeters sold in the U.S. This study test the Nihon Kohden pulse oximeter and SpO2 sensors in neonatal and pediatric patients.

Conditions

• Hypoxemia

Interventions

Type	Name	Description
DEVICE	Pulse oximeter	OLV-4201 pulse oximeter with sensors: TL-272T3, TL-274T3 and TL-273T3

Timeline

• Start date: 2025-11-12
• Primary completion: 2027-11-01
• Completion: 2028-11-01
• First posted: 2025-09-11
• Last updated: 2025-11-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study